FDA Inspection
Amann Girrbach North America, L.P.Amann Girrbach North America, L.P. – FDA Inspection, Aug 29, 2018
Record Details
This FDA Inspection record concerns Amann Girrbach North America, L.P., with an inspection on August 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc66fff3-4929-451e-908c-1d1f4d944e71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063743
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.72(a)Equipment control activity documentation
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